During major surgery bleeding may occur at various internal wounds located within the body. Herein the term "wound" is used in its most generic sense. For example, an ulcerated and bleeding carcinoma of the stomach would be a wound, hemorrhaging varicose veins from the esophagus would also be a wound, bleeding from a paraspinal vessel would be considered a wound, also a weak and leaking vascular suture would be a wound. Bleeding from each one of these wounds is normally stopped by direct application of finger pressure by a member of the surgical team. During operative procedures, time may not permit stopping the operation or extending the duration of the operation until bleeding from the wound ceases. When the bleeding continues after the operative procedures are complete, the site of the wound may be packed with gauze until the bleeding stops.
The need, therefore, exists to provide a device which will apply prolonged direct pressure to a bleeding wound both during the time period that additional operative procedures are being carried out and after the period that the operative procedures have been completed. Additionally, pressure on the wound should be controllable from outside of the body of the patient. Even with today's advanced surgical practices, there are still clinical pathological situations which result in bleeding from the gastrointestinal tract where more blood is thrown out of the vascular system than can be replaced by transfusion of fresh blood through the veins. In that case, agressive surgery could become too risky. In this situation, a simple laparotomy with hydrostatic pressure control on the bleeding area could be life saving. In addition, the control of the vascular oozing could be prolonged for days until the conditions are more manageable.
In contrast with the gauze-packing pressure application method, the present invention provides a selective controllable, pressure application system using a hydrostatic column which, unlike the gauze packing method, is not influenced by the movements of the compressed organ. This is because the device of the present invention is stitched to the organ itself where the bleeding area circumscribed by the stitches is unchangeable.
Finally, in order to minimize the risk to the patient, the device for applying pressure to the point of internal bleeding should be easily removable from the body after the bleeding from the internal wound has stopped.
The use of hydraulic pressure devices to apply direct pressure to a wound for the control of bleeding was recognized in U.S. Pat. Nos. 1,051,850 to Sandmark and 2,179,964 to Stevens. These two patents illustrate devices which may be inserted in the nasal passage to stop nasal bleeding by the use of an inflatible device. The application of hydraulic or pneumatic pressure to the exterior surface of the body was recognized in U.S. Pat. Nos. 3,171,410 to Towle et al, 3,625,219 to Abrams, 3,874,387 to Barbieri, and 4,233,980 to McRae et al. None of the devices can be used for direct application of pressure to the site of internal bleeding.
While not related to the stoppage of bleeding, U.S. Pat. No. 4,207,891 to Bolduc, envisions the use of an inflatible device for the application of medication within the uterine cavity of a female. While describing the use of an inflatable device within the body of a patient, this device is not to be used for the problem of stopping bleeding from an internal wound by the application of direct pressure.
Consequently, a void exists in the art for a device which can be used to apply direct pressure to an internal bleeding wound during and after the completion of surgical procedures. Additionally, a need exists in the art to provide a device which can be easily removed from the body once bleeding from the internal wound has stopped.